Study Specialist II
12 Months
HYBRID Role - 2x a week onsite
San Rafael, CA
Max PR: $45.31
Role Summary
The Study Specialist II (SS-II) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget. Within the role the candidate is expected to show and have proficient knowledge and experience in the following competencies:
Core Competencies:
- Agility and Proactivity
- Communication and Collaboration
Technical competencies:
- Study Management and Execution
- Compliance and Quality
- Drug Development and Study Design
- Product and Therapeutic Area Knowledge
Responsibilities include but are not limited to:
- Develop and/or review study specific documentation, as delegated by the Study Manager
- Contribute to the management of country and site feasibility assessment
- Provide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sites
- Contribute to the collection and oversight of essential documents for study life-cycle management
- Contribute to the development of site and investigator training materials
- May present at investigator meetings as assigned
- Ensure timely study entry and updates to ClinicalTrials.gov
- Ensure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor)
- Provide administrative assistance with internal and external meetings including investigator meeting(s) as warranted
- Facilitate Screening Authorization Forms tracking/sign off where applicable
- Manage various Global Study Operations document translations as applicable
- Process documents for signature in DocuSign
- Site management for delegated site(s)
- Manage and resolve site related issues and risks escalated to company that can't be resolved by CRO.
- Contribute to identifying risks identification and mitigations
- Oversee the Clinical Trial Insurance process
- Support Study Manager to ensure timely delivery and handling of IP to the sites
- Support Vendor Management
- Attend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
- Oversee and manage essential documents in the Trial Master File (TMF)
- Contribute to Global Study Operations risks identification and mitigations.
- Provide support and administrative assistance with internal and external meetings
- Assist with filing GSO internal study documents in internal systems
Education
- BS or higher in nursing, life or health sciences is preferred
- Industry or relevant experience in lieu of education may be considered
- Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)